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The Pipeline Report 2013: Late-Stage Standouts

PRODUCTS GENERATING BUZZ
Fostamatinib (R788) AstraZeneca + RigelIndication: Rheumatoid arthritis (Phase III)What the clinical trials found: In Phase IIb, patients achieving ACR20 ranged from 37-66%, depending on dosage, at six months. There were minimal safety issues.inThought Approvability Index and Comment: 55%. Fostamatinib, an oral RA drug, is the most advanced syk inhibitor, an alternative to JAK inhibitors like Pfizer's recently approved Xeljanz (tofacitinib). AZ/Rigel, and the developers of other syk and JAK inhibitors, could also gain an edge over Xeljanz if they can develop once-daily dosing. Estimated approval: Sept. 2014 (Source: Symphony Health Solutions)inThought revenue forecast: $657 million in annual sales by 2019.

Infliximab biosimilar/CT-P13 CelltrionIndication: Rheumatoid arthritis (Phase III)What the clinical trials found: In Phase III, 73.4% of patients taking CT-P13 achieved an ACR20 score (20% improvement; the level considered minimally clinically important) at week 30, vs. 69.7% for J&J/Merck's Remicade (infliximab). Safety was comparable.inThought Comment: Celltrion, which has been quite transparent about its biosimilar of Remicade, may be able to get it approved as a branded drug in the US. Rather than making it the first true biosimilar monoclonal antibody in the US, an approval would make CT-P13 the sixth TNF inhibitor drug in the market. Estimated approval: 2017 (Source: Symphony Health Solutions)inThought revenue forecast: TNF biosimilars will generate $1.1 billion in peak annual sales by 2019, but how that's divided up among Celltrion and other players is the big unknown.What the analysts are saying: In the US, responses from patients and physicians have been mixed. Some want lower prices and are looking forward to a biosimilar Remicade, and others are leery about its safety and efficacy. Its precise impact remains to be seen. However, analysts say Remicade sales are likely to decline in 2017, so the transition from Remicade, if it continues to work well, will be gradual. Also, price estimates for biosimilar Remicade range from 10-50% of Remicade's cost. If the savings are not as dramatic, will that provide sufficient motivation for doctors to prescribe and patients to try a biosimilar Remicade? —Joanne French, VP, health practice, GfK HealthCare

Odanacatib MerckIndication: Osteoporosis (Phase III)What the clinical trials found: In Phase IIb, odanacatib improved bone mineral density at a higher rate vs. placebo and was generally well tolerated. In July a Phase III trial was stopped early because of positive results and a favorable benefit-to-risk profile.inThought Approvability Index and Comment: 60%. It's difficult to see how this drug can compete effectively against the bisphosphonates, which have been so successful and so inexpensive. A niche of patients who don't tolerate bisphosphonates well would be candidates, but that's already the niche Prolia (Amgen) fills, and Prolia revenues are not all that exciting. Lack of head-to-head data with bisphosphonates is surprisingly absent from the Merck program. Estimated approval: February 2014 (Source: Symphony Health Solutions)inThought revenue forecast: $1.5 billion in annual sales in 2019.
What the analysts are saying: Odanacatib could succeed Merck's Fosamax, which had $3 billion in annual sales before its patent expired in 2008. Current options are limited: patients link the bisphosphonates to osteonecrosis of the jaw and atypical fractures, and most don't want injections. Odanacatib should do what previous therapies cannot—block the main culprit of existing bone tissue breakdown (the CatK enzyme) while allowing the osteoblast to form bone. Whether patients will be required to try generic Fosamax before odanacatib depends on final clinical trial results. —Harris Kaplan, CEO, Healogix

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